{"id":2640315,"url":"https://alion.io/job/skillcloud-regulatory-affairs-manager","title":"Regulatory Affairs Manager","company":{"id":685243,"name":"Skillcloud","domain":"skillcloudhcm.com","url":"https://alion.io/company/skillcloudhcm","size_band":null,"is_staffing_agency":true,"employer_type":"agency","is_intermediary":false,"listed_via":null,"ats_vendor":"Lever","truth_index":{"grade":"A","score":95,"open_postings":3,"ghost_share":0,"stale_share":0,"repost_share":0,"time_to_fill_p50_days":64,"computed_at":"2026-10-16T05:45:00Z"}},"role":"Public Policy","role_family":"Public Policy","seniority":"senior","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":[],"countries":[],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":120000,"max":140000,"currency":"USD","period":"year","gross":null,"usd_annual":140000},"salary_estimate":null,"experience_years_min":7,"visa_sponsorship":false,"relocation_package":false,"has_equity":true,"technologies":[],"status":"live","first_seen_at":"2026-10-15T14:56:15Z","employer_posted_date":"2026-10-15","last_verified_at":"2026-10-16T10:30:37Z","board_verified":true,"closed_at":null,"days_open":0,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":0},"description":"FHC, Inc\nRegulatory Affairs Manager\nBowdoin, Maine OR Greenville, PA (Hybrid)\nFHC, Inc is searching for aRegulatory Affairs Manager to be based in New England or Western Pennsylvania and work hybrid with the ability to be onsite in Bowdoin, Maine or Greenville, PA as needed. FHC, Inc. has served the neuroscience community for over 50 years. With a guiding principle of innovation through collaboration, FHC designs, manufactures, and internationally markets products that provide customizable, pioneering solutions for neuroscientists, neurologists, and neurosurgeons and has been recognized on the Best Places to Work in Maine list for 2026.\nJob Summary:\nThe Regulatory Affairs Manager is responsible for leading and overseeing the Company's global regulatory affairs activities to ensure compliance with applicable medical device regulations and standards in all markets where products are manufactured, marketed, distributed, or sold. This position develops and executes regulatory strategies that support product development, market access, business growth, and post-market compliance activities.\nWhat We Offer:\nSalary in the range of $120-140K\n\nHealth andDental Insuranceoptions\n\n401K with company match\n\nEmployee Stock Ownership Plan\n\nGenerous PTO, holiday pay, paid sick time\n\nUp to $1000/ year for approved professional development\n\nOptions for Life Insurance, HSAand DCA Accounts\n\nFlexible work schedule with the opportunity for hybrid work 1-2 days/week\n\nQualifications:\nBachelor's degree in Engineering, Biomedical Engineering, Life Sciences, Regulatory Affairs, Quality, or related technical discipline required.Master's degree preferred.\n\nMinimum of 7-10 years of medical device regulatory affairs experience.\n\nMinimum of 3 years of leadership, supervisory, or project leadership experience.\n\nDemonstrated experience with FDA submissions, international registrations, and global market access activities.\n\nExperience with FDA, MDR, UK, Canada, and MDSAP requirements.\n\nExperience with Class II and/or Class III medical devices preferred.\n\nExperience supporting ISO 13485-certified and FDA-regulated environments required.\n\nRAC (Regulatory Affairs Certification), ASQ Certified Quality Auditor (CQA), ASQ Certified Quality Engineer (CQE), ISO 13485 Lead Auditor Certification preferred.\n\nResponsibilities:\nDevelop and implement global regulatory strategies that support product development, commercialization, and lifecycle management of medical devices.\n\nProvide regulatory leadership and guidance throughout all phases of product design, development, verification, validation, release, and post-market support.\n\nAdviseexecutive leadership on regulatory risks, opportunities, emerging regulations, and business impacts.\n\nLead, mentor, and develop Regulatory Affairs personnel.\n\nOversee preparation, review, submission, and maintenance of regulatory filings.\n\nEnsure timely maintenance of product registrations in all approved markets.\n\nManage interactions with regulatory authorities, notified bodies, distributors, and international representatives.\n\nEnsure regulatory compliance is integrated into the Quality Management System (QMS).\n\nParticipate in internal audits, external audits, supplier audits, and regulatory inspections.\n\nCollaborate with Engineering and Product Development teams to ensure regulatory requirements are appropriately incorporated into product designs.\n\nProvide regulatory review and approval of product claims, labeling, instructions for use, advertising, promotional materials, and marketing communications.\n\nSupport design reviews and development projects as a core regulatory stakeholder.\n\nMaintain awareness of emerging regulations, guidance documents, standards, and industry best 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